- ThermoFisher Scientific (Lawrenceville, NJ)
- …to quantify drugs and related compounds in biological samples to support drug development and regulatory filings. **Essential Functions:** * Perform method ... archival * Knowledge of GLP, 21 CFR Part 11, Regulatory Bioanalytical Guidance and general laboratory practices * Possess...job * Preferred: 2+ years in CRO or GLP regulatory lab environment In some cases, an equivalency, consisting… more
- University of Southern California (San Diego, CA)
- …AssociateApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/San-Diego-CA/Clinical-Research- Associate \_REQ20160224/apply) Keck School of Medicine San ... Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: +… more
- PNC (Tampa, FL)
- …+ Identifies and appropriately mitigates different types of risk, such as regulatory , reputational, and operational. Manages risk and may help ensure quality for ... in the decision-making process, such as internal policies/procedures, external regulatory requirements and clients' needs. + Interacts with internal/external clients… more
- Stryker (Arroyo, PR)
- …a critical role in ensuring that products meet the highest quality and regulatory standards. The individual will be responsible for defining and maintaining quality ... + Ensure full compliance with FDA, ISO13485, and other applicable regulatory and quality standards across operations and suppliers. + Define, approve,… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. + ... Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with advancements in… more
- SUNY Upstate Medical University (Syracuse, NY)
- …at the Sponsor Level including but not limited to: procuring study drug , site selection and management, vendor selection, consent form development, study document ... protocol deviation reporting and management, communication and periodic reporting to regulatory agencies and financial sponsors, secure and track all regulatory… more
- Lilly (Indianapolis, IN)
- …and adoption of best practices. + Compliance: Ensure adherence to regulatory requirements, data privacy, and security standards. **What You Should Bring:** ... for innovation and continuous learning. + Compliance Awareness: Knowledge of regulatory , privacy, and security standards relevant to the pharmaceutical industry.… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …managed, governed, and secured, following industry best practices and regulatory requirements. + Model Otsuka's core competencies (Accountability for Results, ... Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/ Regulatory /Legal integrated business partners. **Minimum Qualifications:** + Minimum bachelor's… more
- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. Senior Associate **What you will do** Let's do this. Let's change the world. In this ... mechanistic understanding and application of RNA technologies, and potential clinical drug development. The candidate will use their experimental background in… more
- Truist (Charlotte, NC)
- …States of America) **Please review the following job description:** The ALM Senior Associate will serve as a senior subject matter expert (SME) responsible for ... Planning at the enterprise level, Interest Rate Risk Management scenarios, and regulatory stress test scenarios. In addition, the team engages in project initiatives… more